Chronic UveitisPhase 3EYEGUARD-XNCT02375685
Long-term Safety of Gevokizumab in the Treatment of Patients With Chronic Non-infectious Uveitis (EYEGUARD-X)
A Phase 3 study testing Gevokizumab in people with Chronic Uveitis, run by Institut de Recherches Internationales Servier at 13 sites in 13 countries.
Trial summary
The objective of this study is to evaluate long-term safety of gevokizumab in patient with chronic non-infectious uveitis who previously well tolerated the study drug and may benefit from longterm treatment with gevokizumab. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Chronic Uveitis
- What is being tested?
- Gevokizumab
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 71 participants
- Where
- 13 sitesin 13 countries
- Study dates
- Aug 2014to Nov 2015
- Phase
- Phase 3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- either completed participation to one of the following: CL3-78989-002 open-label extension, or X052130/CL3-78989-005 double-masked period or open-label period, or X052131/CL3-78989-006 double-masked period or open-label period, or currently benefiting from gevokizumab compassionate use after participation in gevokizumab uveitis studies
- Male or female, age ≥18 (or legal age of majority in the country) at selection.
- For subject with reproductive potential, a willingness to use highly effective contraceptive measures
Who cannot join
- Meeting criteria for discontinuation of any of gevokizumab uveitis previous study.
- Infectious uveitis and masquerade syndrome
- History of severe allergic or anaphylactic reaction to study drug administration during previous study or to gevokizumab or any of its excipient.
- Currently active infectious disease.
- Other protocol-defined inclusion/exclusion criteria may apply
Trial locations and contacts
13 sites in 13 countries.
13 sites in 13 countries
United Kingdom1 site
Moorfields Eye Hospital NHS Foundation Trust
London, EC1V 2PD
About this study
Official title: A Safety Open-label Study of Gevokizumab in the Treatment of Patients With Chronic Non-infectious Uveitis Disease, an eXtension Study. The EYEGUARD-X Study
The objective of this study is to evaluate long-term safety of gevokizumab in patient with chronic non-infectious uveitis who previously well tolerated the study drug and may benefit from longterm treatment with gevokizumab.
- Conditions
- Chronic Uveitis
- Being tested
- Gevokizumab
- Keywords
- Uveitis, Non-infectious Uveitis, Intermediate Uveitis, Posterior Uveitis, Behçet's disease uveitis
- Medical subject headings
- Uveitis, Uveitis, Intermediate, Uveitis, Posterior
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
GevokizumabBiological
| Study group | Role | What they receive |
|---|---|---|
| gevokizumab | Experimental | Not described Receives: Biological: Gevokizumab |
What is being measured
The primary outcome is the main question the study is designed to answer.
Safety endpoints (adverse events, ...)
Measured: 108 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Mar 2015 (estimated)
- Study startAug 2014
- Primary completionNov 2015
- Study completionNov 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Chronic UveitisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 71 participants (actual)
Sponsor and investigators
- Lead sponsor
- Institut de Recherches Internationales Servier
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02375685
- Sponsor's protocol ID
- CL3-78989-019
- Other IDs
- 2013-004973-29
- Acronym
- EYEGUARD-X
- Status last verified
- Jan 2020
- First submitted
- 16 Feb 2015
- Last updated
- 3 Jan 2020
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- Yes: Researchers can ask for a study protocol, patient-level and/or study-level clinical trial data including clinical study reports (CSRs). They can ask all interventional clinical studies: * submitted for new medicines and new indications approved after 1 January 2014 in the European Economic Area (EEA) or the United States (US). * Where Servier or an affiliate are the Marketing Authorization Holders (MAH). The date of the first Marketing Authorization of the new medicine (or the new indication) in one of the EEA Member States will be considered within this scope.
Publications
Tugal-Tutkun I, Pavesio C, De Cordoue A, Bernard-Poenaru O, Gul A. Use of Gevokizumab in Patients with Behcet's Disease Uveitis: An International, Randomized, Double-Masked, Placebo-Controlled Study and Open-Label Extension Study. Ocul Immunol Inflamm. 2018;26(7):1023-1033. doi: 10.1080/09273948.2017.1421233. Epub 2018 Jan 25.
PubMed 29370572
Study at a glance
From the registry record, last updated by the sponsor on 3 Jan 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Safety Open-label Study of Gevokizumab in the Treatment of Patients With Chronic Non-infectious Uveitis Disease, an eXtension Study. The EYEGUARD-X Study
- ClinicalTrials.gov ID
- NCT02375685
- Acronym / sponsor ID
- EYEGUARD-X / CL3-78989-019
- Conditions
- Chronic Uveitis
- Keywords
- Uveitis, Non-infectious Uveitis, Intermediate Uveitis, Posterior Uveitis, Behçet's disease uveitis
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Terminated
- Enrolment
- 71 participants (actual)
- Lead sponsor
- Institut de Recherches Internationales ServierUniversity, hospital or other
- Study start
- Aug 2014
- Primary completion
- Nov 2015 (actual)
- Study completion
- Nov 2015 (actual)
- First posted
- 3 Mar 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The objective of this study is to evaluate long-term safety of gevokizumab in patient with chronic non-infectious uveitis who previously well tolerated the study drug and may benefit from longterm treatment with gevokizumab.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| gevokizumab | Experimental | Biological: Gevokizumab |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- either completed participation to one of the following: CL3-78989-002 open-label extension, or X052130/CL3-78989-005 double-masked period or open-label period, or X052131/CL3-78989-006 double-masked period or open-label period, or currently benefiting from gevokizumab compassionate use after participation in gevokizumab uveitis studies
- Male or female, age ≥18 (or legal age of majority in the country) at selection.
- For subject with reproductive potential, a willingness to use highly effective contraceptive measures
Key exclusion criteria (5 listed)
- Meeting criteria for discontinuation of any of gevokizumab uveitis previous study.
- Infectious uveitis and masquerade syndrome
- History of severe allergic or anaphylactic reaction to study drug administration during previous study or to gevokizumab or any of its excipient.
- Currently active infectious disease.
- Other protocol-defined inclusion/exclusion criteria may apply
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Gevokizumab | Biological | gevokizumab |
Primary outcome
Safety endpoints (adverse events, ...)
Time frame: 108 weeks
Results and safety
The study was stopped early. Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Jan 2020.
- Results publication: PubMed 29370572Tugal-Tutkun I, Pavesio C, De Cordoue A, Bernard-Poenaru O, Gul A. Use of Gevokizumab in Patients with Behcet's Disease Uveitis: An International, Randomized, Double-Masked, Placebo-Controlled Study and Open-Label Extension Study. Ocul Immunol Inflamm. 2018;26(7):1023-1033. doi: 10.1080/09273948.2017.1421233. Epub 2018 Jan 25.
- Genetics Home ReferenceLink provided by the sponsor.
- U.S. FDA ResourcesLink provided by the sponsor.
- Individual participant dataSharing planned: Yes. Researchers can ask for a study protocol, patient-level and/or study-level clinical trial data including clinical study reports (CSRs). They can ask all interventional clinical studies: * submitted for new medicines and new indications approved after 1 January 2014 in the European Economic Area (EEA) or the United States (US). * Where Servier or an affiliate are the Marketing Authorization Holders (MAH). The date of the first Marketing Authorization of the new medicine (or the new indication) in one of the EEA Member States will be considered within this scope.
Related trials for Chronic Uveitis
Not yet recruitingPhase 4
Adalimumab Dose Adjustment for Pediatric Uveitis Treatment Trial
Juvenile Idiopathic Arthritis Associated Uveitis, Uveitis, Anterior
Not yet recruitingPhase 4
Therapeutic Drug Monitoring-baSed adalimuMab De-escalatiOn in nOn-infecTious cHronic Uveitis
Uveitis, Chronic Disease
Recruiting
Deployment o the Multidisciplinary Prospective Cohort Imminent
Chronic Inflammatory Disease, Angioedema
Active, not recruitingPhase 3
A Study of Baricitinib (LY3009104) in Participants From 2 Years to Less Than 18 Years Old With Active JIA-Associated Uveitis or Chronic Anterior Antinuclear Antibody-Positive Uveitis
Uveitis
RecruitingObservational study
RChildUV:Study on Non-infectious Chronic Uveitis in Pediatric Age
Uveitis
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
13 sites in 13 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Gevokizumab in people with Chronic Uveitis, run by Institut de Recherches Internationales Servier at 13 sites in 13 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 3 Jan 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 13 sites in Australia, Austria, France, Germany, Greece and 8 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was stopped early. Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Safety endpoints (adverse events, ...) (time frame: 108 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02375685, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Jan 2020.